CONCERTO II CRT-D, CONSULTA & DF4, MAXIMO II CRT-D & DF4, PROTECTA CRT-D & DF4 & XT CRT-D & XT DF4
FDA premarket approval P010031/S303 · decided 2012-05-23
Approval details
- PMA number
- P010031
- Supplement
- S303
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II CRT-D, CONSULTA & DF4, MAXIMO II CRT-D & DF4, PROTECTA CRT-D & DF4 & XT CRT-D & XT DF4
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-04-25
- Decision date
- 2012-05-23
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE TO THE DIE ATTACH CURE PROCESS FOR SELECTED SILICON-CONTROLLED RECTIFIER COMPONENTS.
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